BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA ASP300S

    MDR report key: 3809802 · Received April 28, 2014

    Report

    Report Number
    8010478-2014-00005
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    December 12, 2013
    Report Date
    March 31, 2014
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT HAS BEEN EVALUATED TY A LEICA APPLICATION SPECIALIST. THE INVESTIGATION REVEALED THE FOLLOWING" THE ROOT CAUSE IS DETERMINED TO BE USER ERROR RELATED. THE CUSTOMER HAD INTERCHANGED THE REAGENTS, BECAUSE THIS EVENT WAS A SUDDEN DETERIORATION AND NOT A GRADUAL PROCESS. ACCORDING THE CUSTOMER THE LAST TIME OF CHANGING THE REAGENTS WAS THE DAY BEFORE THE EVENT OCCURRED. AFTER THE EVENT THE REAGENTS WERE CHANGED AND THE CUSTOMER CONDUCTED A NEW PROCESSING RUN WHICH CONFIRMED THE PROPER FUNCTIONING OF THE UNIT. A CUSTOMER FACING LETTER WILL BE SENT TO THE CUSTOMER WITH THE REFERENCE IN FUTURE TO FOLLOW THE RECOMMENDATION IN THE CUSTOMER LETTER REGARDING THE REAGENT HANDLING.

    Description of Event or Problem · 1

    ON (B)(6) 2014, LEICA BIOSYSTEMS RECEIVED INFO FROM THE CUSTOMER THAT ONE PATIENT SAMPLE NEEDED TO BE RE-BIOPSIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254410 LEICA ASP300S TISSUE PROCESSOR IEO LEICA BIOSYSTEMS NUSSLOCH GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other